Influence of Training Intensity in Coronary Artery Disease

Coronary Artery Disease Clinical Trial

Official title:

Influence of Training Intensity on Exercise Capacity and Risk Profile in Coronary Artery Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03034980
• Other study ID #: PD-VG-01
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: February 26, 2018
• Start date: December 20, 2016
• Est. completion date: September 15, 2017

Study information

• Verified date: February 2018
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronary artery disease (CAD) is associated with high mortality worldwide. Narrowing of the coronary arteries can cause an acute myocardial infarction. Patient with cardiac ischemia are often treated with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). Following hospitalisation, the patients are offered to attend a classical rehabilitation program with moderate exercise intensity. Current exercise program for cardiac rehabilitation has proven to reduce cardiovascular risk factors 1. Is it possible to improve the exercise capacity and risk profile even more if the exercise program includes more vigorous training? The program starts one week after the cardiac incident (AMI, PCI or CABG) and takes 12 weeks to complete. Patients with heart failure and valvular disease are excluded. First ventilatory threshold (VT1) and second ventilatory threshold (VT2) are determined during cycloerometry. VT2 reflects aerobic-anaerobic transition and therefore the aerobic functional capacity2. Exercise load reached at VT2 is used to determine the training load during rehabilitation.

The research goal is to investigate the influence of training intensity on the exercise capacity and risk profile of CAD patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 343
• Est. completion date: September 15, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients with acute myocardial infarction (AMI), who underwent a percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). The 12-week program must be completed.

Exclusion Criteria:

• Patients with heart failure (HFpEF and HFrEF with ejection fraction =40%) and valvular heart disease.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• Training intensity (workload) during ergospirometry
The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.

Locations

Country	Name	City	State
Belgium	Jessa Ziekenhuis	Hasselt

Sponsors (2)

Lead Sponsor	Collaborator
Hasselt University	Jessa Hospital

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exercise capacity	The primary endpoint is the relationship between the actual training load (W) and exercise capacity (VO2max) obtained at the end of the rehabilitation.	up to week 12
Secondary	cardiovascular risk profile	The secondary endpoint is the relationship between relative training load and the cardiovascular risk factors.	up to week 12